A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children

NCT05543616 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: C45910482024-000001-332023-503736-40-00
• Study Type: interventional
• Target: 4,292
• Locations: 5 countries
• Sites: 96

Brief Summary

The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 5 sub-studies will receive study vaccine as a shot depending on what group they are in.

• Substudy A design: Phase 1 includes participants 6 months through less than 4 years 3 months of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial series, followed by a fourth dose of study vaccine. Phase 2/3 includes participants 6 months through less than 5 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive 1, 2, or 3 doses of study vaccine, depending on what group they are in.
• Substudy B design: includes participants 6 months through less than 5 years of age who have either received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose.
• Substudy C design: Phase 1 includes participants 6 months through less than 5 years of age who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose.
• Substudy D design: includes participants 5 through less than12 years of age who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose.
• Substudy E design: includes participants 5 through less than 12 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive a single dose of study vaccine.

Conditions

SARS-CoV-2 Virus; Severe Acute Respiratory Syndrome Coronavirus 2; COVID-19

Keywords

COVID-19; Coronavirus; Vaccine; SARS-CoV-2; RNA Vaccine

Outcome Measures

Primary Outcomes (37)

• Substudy A (SSA) - Ph 1 dose finding, percentage of participants reporting local reactions

  Participants ≥6 months to \<2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to \<5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries

  for up to 7 days following Dose 1, Dose 2, Dose 3 and Dose 4

• SSA - Ph 1 dose finding, percentage of participants reporting systemic events

  Participants ≥6 months to \<2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to \<5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

  for up to 7 days following Dose 1, Dose 2, Dose 3 and Dose 4

• SSA - Ph 1 dose finding, percentage of participants reporting adverse events

  as elicited by investigational site staff

  from Dose 1 to 1 month after Dose 3 and from Dose 4 to 1 month after Dose 4

• SSA - Ph 1 dose finding, percentage of participants reporting serious adverse events

  as elicited by investigational site staff

  from Dose 1 to 6 months after the last dose

• SSA - Ph 2/3, percentage of participants reporting local reactions

  Participants ≥6 months to \<2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to \<5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries

  for up to 7 days following Dose 1 (for Groups 1 through 6), Dose 2 (for Groups 1, 2, 3, and 6), and Dose 3 (for Group 3)

• SSA - Ph 2/3, percentage of participants reporting systemic events

  Participants ≥6 months to \<2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to \<5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

  for up to 7 days following Dose 1 (for Groups 1 through 6), Dose 2 (for Groups 1, 2, 3, and 6), and Dose 3 (for Group 3)

• SSA - Ph 2/3, percentage of participants reporting adverse events

  as elicited by investigational site staff

  from Dose 1 to 1 month after the last dose

• SSA - Ph 2/3, percentage of participants reporting serious adverse events

  as elicited by investigational site staff

  from Dose 1 to 6 months after the last dose

• SSA - Ph 2/3, noninferiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron XBB.1.5-neutralizing titers in participants ≥6 months to <2 years of age

  As measured at the central laboratory

  At 1 month after 2 doses of BNT162b2 (Omicron XBB.1.5) 10 microgram (on a 0- and 8-week schedule) to 1 month after 3 doses (on a 0-, 3-, and 11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram

• SSA - Ph 2/3, noninferiority with respect to seroresponse rate to the Omicron XBB.1.5 strain titers in participants ≥6 months to <2 years of age

  As measured at the central laboratory

  At 1 month after 2 doses of BNT162b2 (Omicron XBB.1.5) 10 microgram (on a 0- and 8-week schedule) and at 1 month after 3 doses (on a 0-, 3-, and 11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram

• SSA - Ph 2/3, noninferiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron XBB.1.5-neutralizing titers in participants ≥2 to <5 years of age

  As measured at the central laboratory

  At 1 month after 1 dose of BNT162b2 (Omicron XBB.1.5) 10 microgram in participants ≥2 to <5 years of age to 1 month after 3 doses (on a 0/3/11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram in participants ≥6 months to <2 years of age

• SSA - Ph 2/3, noninferiority with respect to seroresponse rate to the Omicron XBB.1.5 strain in participants ≥2 to <5 years of age

  As measured at the central laboratory

  At 1 month after 1 dose of BNT162b2 (Omicron XBB.1.5) 10 microgram in participants ≥2 to <5 years of age and at 1 month after 3 doses (0/3/11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram in participants ≥6 months to <2 years of age

• Substudy B (SSB) - percentage of participants reporting local reactions

  Participants ≥6 months to \<2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to \<5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries

  for up to 7 days following Dose 1 (for Groups 1, 2 and 3) and Dose 2 (for Group 1)

• SSB - percentage of participants reporting systemic events

  Participants ≥6 months to \<2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to \<5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

  for up to 7 days following Dose 1 (for Groups 1, 2 and 3) and Dose 2 (for Group 1)

• SSB - percentage of participants reporting adverse events

  as elicited by investigational site staff

  from the first study vaccination to 1 month after the first study vaccination (for Groups 1, 2, and 3), and from the second study vaccination to 1 month after the second study vaccination (for Group 1 only)

• SSB - percentage of participants reporting serious adverse events

  as elicited by investigational site staff

  from Dose 1 to 6 months after the last dose

• SSB - superiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <5 years of age

  As measured at the central laboratory

  at 1 month after Dose 4 for Group 2 participants who received 3 prior doses of BNT162b2 3 µg and a fourth dose of bivalent BNT162b2 to 1 month after Dose 3 in Study C4591007 participants ≥6 months to <5 years of age who received 3 doses of BNT162b2 3 µg

• SSB - noninferiority with respect to seroresponse rate to the Omicron BA.4/BA.5 strain in participants ≥6 months to <5 years of age

  As measured at the central laboratory

  at 1 month after Dose 4 for Group 2 participants who received 3 prior doses of BNT162b2 3 µg and a fourth dose of bivalent BNT162b2 to 1 month after Dose 3 in Study C4591007 participants ≥6 months to <5 years of age who received 3 doses of BNT162b2 3 µg

• Substudy C (SSC) - Ph 1 dose finding, percentage of participants reporting local reactions

  Participants ≥6 months to \<2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to \<5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries

  for up to 7 days following Dose 1

• SSC - Ph 1 dose finding, percentage of participants reporting systemic events

  Participants ≥6 months to \<2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to \<5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

  for up to 7 days following Dose 1

• SSC - Ph 1 dose finding, percentage of participants reporting adverse events

  as elicited by investigational site staff

  1 month after Dose 1

• SSC - Ph 1 dose finding, percentage of participants reporting serious adverse events

  as elicited by investigational site staff

  6 months after Dose 1

• SSC - Ph 1 dose finding - geometric mean titers elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age

  As measured at the central laboratory

  At baseline (before Dose 1) and 1 month after Dose 1

• SSC - Ph 1 dose finding - geometric mean fold rise elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age

  As measured at the central laboratory

  At baseline (before Dose 1) and 1 month after Dose 1

• SSC - Ph 1 dose finding - percentage of participants with seroresponse elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age

  As measured at the central laboratory

  At baseline (before Dose 1) and 1 month after Dose 1

• Substudy D (SSD) - percentage of participants reporting local reactions

  pain at the injection site, redness, and swelling as self-reported on electronic diaries

  for up to 7 days following Dose 1

• SSD - percentage of participants reporting systemic events

  fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

  for up to 7 days following Dose 1

• SSD - percentage of participants reporting adverse events

  as elicited by investigational site staff

  1 month after Dose 1

• SSD - percentage of participants reporting serious adverse events

  as elicited by investigational site staff

  6 months after Dose 1

• SSD - the ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥5 to <12 years of age

  As measured at the central laboratory

  at 1 month after Dose 4 for participants who received 3 prior doses of BNT162b2 10 μg and a fourth dose of bivalent BNT162b2 to those at 1 month after Dose 3 for Study C4591007 Phase 2/3 participants who received 3 doses of BNT162b2 10 μg

• SSD - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain in participants ≥5 to <12 years of age

  As measured at the central laboratory

  at 1 month after bivalent BNT162b2 as a fourth dose for participants who received 3 prior doses of BNT162b2 10 µg and at 1 month after a third dose of BNT162b2 10 µg for Study C4591007 Phase 2/3 participants who received 3 doses of BNT162b2 10 µg

• Substudy E (SSE) - percentage of participants reporting local reactions

  pain at the injection site, redness, and swelling as self-reported on electronic diaries

  for up to 7 days following Dose 1

• SSE - percentage of participants reporting systemic events

  fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

  for up to 7 days following Dose 1

• SSE - percentage of participants reporting adverse events

  as elicited by investigational site staff

  from Dose 1 to 1 month after Dose 1

• SSE - percentage of participants reporting serious adverse events

  as elicited by investigational site staff

  from Dose 1 to 6 months after Dose 1

• SSE - Ratio of the geometric mean of SARS-CoV-2 Omicron XBB.1.5-neutralizing titers

  As measured at the central laboratory

  At 1 month after 1 dose of BNT162b2 (Omi XBB.1.5) 10 microgram in participants ≥5 to 12 years of age to 1 month after 1 dose of BNT162b2 (Omi XBB.1.5) 30 microgram in participants ≥12 years of age from study C4591054 Substudy A

• SSE - difference in percentage of participants with seroresponse to Omicron XBB.1.5

  As measured at the central laboratory

  At 1 month after 1 dose of BNT162b2 (Omi XBB.1.5) 10 microgram in participants ≥5 to 12 years of age and 1 month after 1 dose of BNT162b2 (Omi XBB.1.5) 30 microgram in participants ≥12 years of age from study C4591054 Substudy A

Secondary Outcomes (17)

• SSA - Ph 1 dose finding, geometric mean titers elicited by prophylactic variant-adapted BNT162b2 at each dose level and variant vaccine type (if applicable) in COVID-19 vaccine-naïve participants ≥6 months to <5 years of age

  At baseline (before Dose 1), 1 month after Dose 2, 1 month after Dose 3, and 1 month after Dose 4

• SSA - Ph 1 dose finding, geometric mean fold rise elicited by prophylactic variant-adapted BNT162b2 at each dose level and variant vaccine type (if applicable) in COVID-19 vaccine-naïve participants ≥6 months to <5 years of age

  At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3

• SSA - Ph 1 dose finding, percentage of participants with seroresponse elicited by prophylactic variant-adapted BNT162b2 at each dose level and variant-adapted vaccine type in COVID-19 vaccine-naïve participants ≥6 months to <5 years of age

  At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3

• SSA - Ph 2/3, geometric mean titers elicited by variant-adapted BNT162b2 (Omicron XBB.1.5) in COVID-19 vaccine-naive participants ≥6 months to <5 years of age

  At baseline (before Dose 1), 1 month after Dose 1 (Groups 2 and 4), 1 month after Dose 2 (Group 1), and 1 month after Dose 3 (Group 3)

• SSA - Ph 2/3, geometric mean fold rise elicited by variant-adapted BNT162b2 (Omicron XBB.1.5) in COVID-19 vaccine naive participants ≥6 months to <5 years of age

  At baseline (before Dose 1), 1 month after Dose 1 (Groups 2 and 4), 1 month after Dose 2 (Group 1), and 1 month after Dose 3 (Group 3)

Study Arms (23)

3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)

EXPERIMENTAL

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose; Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose

6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)

EXPERIMENTAL

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose; Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose

10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)

EXPERIMENTAL

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose; Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 1) - 0/8 week schedule

EXPERIMENTAL

Injection in the muscle at 0- and 8-weeks

Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 2) - 0/8 week schedule

EXPERIMENTAL

Injection in the muscle at 0- and 8-weeks

Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1)

EXPERIMENTAL

Injection in the muscle, 2 doses 2 months apart

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose

3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2)

EXPERIMENTAL

Injection in the muscle, 1 dose

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose

3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3)

EXPERIMENTAL

Injection in the muscle, 1 dose

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose

6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)

EXPERIMENTAL

Injection in the muscle, 1 dose

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose

10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)

EXPERIMENTAL

Injection in the muscle, 1 dose

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

10 microgram dose, 5 to <12 Years (Substudy D, Group 1)

EXPERIMENTAL

Injection in the muscle, 1 dose

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

10 microgram dose, 5 to <12 Years (Substudy D, Group 2)

EXPERIMENTAL

Injection in the muscle, 1 dose

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

10 microgram dose, 5 to <12 Years (Substudy D, Group 3)

EXPERIMENTAL

Injection in the muscle, 1 dose

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)

EXPERIMENTAL

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose; Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose

6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)

EXPERIMENTAL

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose; Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose; Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

10 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)

EXPERIMENTAL

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)

EXPERIMENTAL

Injection in the muscle, 1 dose

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose

10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)

EXPERIMENTAL

Injection in the muscle, 1 dose

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 3) - 0/3/11 week schedule

EXPERIMENTAL

Injection in the muscle at 0-, 3-, and 11-weeks

Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose

10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose

EXPERIMENTAL

Injection in the muscle, 1 dose

Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose

EXPERIMENTAL

Injection in the muscle, 1 dose

Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2)

EXPERIMENTAL

Injection in the muscle, 1 dose

Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

10 microgram dose, 6 months to <2 years (Substudy A Phase 2/3, Group 6) - 0/8 week schedule

EXPERIMENTAL

Injection in the muscle at 0- and 8-weeks

Biological: Variant-adapted BNT162b2 (Omicron KP.2) 10 microgram dose

Interventions

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose BIOLOGICAL

Injection in the muscle

6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1); 6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1); 6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1); 6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose BIOLOGICAL

Injection in the muscle

10 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1); 10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1); 10 microgram dose, 5 to <12 Years (Substudy D, Group 1); 10 microgram dose, 5 to <12 Years (Substudy D, Group 2); 10 microgram dose, 5 to <12 Years (Substudy D, Group 3); 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1); 10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)

Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose BIOLOGICAL

Injection in the muscle

3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1); 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1); 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 3) - 0/3/11 week schedule

Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose BIOLOGICAL

Injection in the muscle

6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1); 6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)

Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose BIOLOGICAL

injection in the muscle

10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose; 10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose; 10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2); 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1); 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 1) - 0/8 week schedule; 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 2) - 0/8 week schedule; 6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)

Variant-adapted BNT162b2 (Omicron KP.2) 10 microgram dose BIOLOGICAL

Injection in the muscle

10 microgram dose, 6 months to <2 years (Substudy A Phase 2/3, Group 6) - 0/8 week schedule

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose BIOLOGICAL

Injection in the muscle

3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1); 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1); 3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1); 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2); 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3)

Eligibility Criteria

• Age: 6 Months - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Phase 1: Healthy male or female participants ≥6 months to \<4 years 3 months of age, at the time of randomization.
• Phase 2/3: Healthy male or female participants ≥6 months to \<5 years of age at the time of randomization/enrollment.

You may not qualify if:

• Previous or current diagnosis of multisystem inflammatory syndrome in children (MIS-C).
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, or individuals who receive treatment with immunosuppressive therapy.
• Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
• Any history of myocarditis or pericarditis.
• Previous vaccination with any COVID-19 vaccine.
• Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy, within 60 days before enrollment through the conclusion of the study. Systemic corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh \>10 kg) for ≥14 days is prohibited from 28 days prior to enrollment through 28 days after administration of study intervention.
• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except palivizumab), from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study.
• Substudy B
• \- Healthy male or female participants = ≥6 months to \<5 years of age, at the time of enrollment.
• Previous or current diagnosis of MIS-C.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, or individuals who receive treatment with immunosuppressive therapy.
• Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus.
• Prior receipt of any COVID 19 vaccine other than BNT162b2.

Sponsors & Collaborators

• BioNTech SE: lead
• Pfizer: collaborator

Study Sites (96)

UAB Child Health Research Unit (CHRU)

Birmingham, Alabama, 35233, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Advanced Research Center Inc.

Anaheim, California, 92805, United States

Location

Kaiser Permanente

Los Angeles, California, 90027, United States

Location

Kaiser Permanente Oakland

Oakland, California, 94611, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Center for Clinical Trials, LLC

Paramount, California, 90723, United States

Location

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Kaiser Permanente Sacramento

Sacramento, California, 95815, United States

Location

PediaClinic

Highlands Ranch, Colorado, 80126, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Yale University- Yale Center for Clinical Investigation

New Haven, Connecticut, 06519, United States

Location

Emerson Clinical Research Institute

Washington D.C., District of Columbia, 20009, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Velocity Clinical Research, Washington DC

Washington D.C., District of Columbia, 20016, United States

Location

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, 32256, United States

Location

Acevedo Clinical Research Associates

Miami, Florida, 33142, United States

Location

Bio-Medical Research LLC

Miami, Florida, 33144, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

SEC Clinical Research

Pensacola, Florida, 32503, United States

Location

PAS Research

Tampa, Florida, 33613, United States

Location

Emory Children's Center Illness POD

Atlanta, Georgia, 30322, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

Location

The Iowa Clinic, P.C.

Ankeny, Iowa, 50023, United States

Location

The Iowa Clinic, P.C.

West Des Moines, Iowa, 50266, United States

Location

The Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

AMR Clinical

Newton, Kansas, 67114, United States

Location

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67207, United States

Location

Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana, 71101, United States

Location

Center for Immunization Research Inpatient Unit

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Center for Immunization Outpatient Clinic

Baltimore, Maryland, 21224, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Boston Medical Center Crosstown Building

Boston, Massachusetts, 02119, United States

Location

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, 39157, United States

Location

Velocity Clinical Research, Hastings

Hastings, Nebraska, 68901, United States

Location

Velocity Clinical Research, Lincoln

Lincoln, Nebraska, 68510, United States

Location

Children's Hospital & Medical Center

Omaha, Nebraska, 68114, United States

Location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Velocity Clinical Research, Binghamton

Binghamton, New York, 13905, United States

Location

SUNY Downstate Health Sciences University

Brooklyn, New York, 11203, United States

Location

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, 28207, United States

Location

Duke Vaccine and Trials Unit

Durham, North Carolina, 27703, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Senders Pediatrics

Cleveland, Ohio, 44121, United States

Location

Velocity Clinical Research, Cleveland

Cleveland, Ohio, 44122, United States

Location

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45409, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

Allegheny Health and Wellness Pavilion

Erie, Pennsylvania, 16506, United States

Location

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818, United States

Location

Coastal Pediatric Research

Charleston, South Carolina, 29414, United States

Location

Tribe Clinical Research, LLC

Greenville, South Carolina, 29607, United States

Location

Coastal Pediatric Research

Summerville, South Carolina, 29486, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Clinical Research Associates Inc

Nashville, Tennessee, 37203, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

Cedar Health Research

Dallas, Texas, 75251, United States

Location

Proactive Clinical Research, LLC

Edinburg, Texas, 78539, United States

Location

ACRC Trials

Frisco, Texas, 75033, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

DM Clinical Research- Cyfair

Houston, Texas, 77065, United States

Location

Dr. Ruben Aleman and Associates

McAllen, Texas, 78504, United States

Location

ACRC Trials (Administrative Site)

Plano, Texas, 75024, United States

Location

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, 22902, United States

Location

Virginia Research Center

Midlothian, Virginia, 23114, United States

Location

Seattle Children's- Building Cure

Seattle, Washington, 98101, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Obras Sociais Irma Dulce

Salvador, Estado de Bahia, 41680-020, Brazil

Location

Centro Médico São Francisco

Curitiba, Paraná, 80810-050, Brazil

Location

Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN

Natal, Rio Grande do Norte, CEP: 59025-050, Brazil

Location

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, 04266-010, Brazil

Location

CHRISTUS - LATAM HUB Center of excellence and innovation S.C.

Monterrey, Nuevo León, 64060, Mexico

Location

Caimed Investigacion En Salud S.A. de C.V.

Mexico City, 06760, Mexico

Location

Sociedad de Metabolismo y Corazon S.C.

Veracruz, 91900, Mexico

Location

Clinical Research Puerto Rico

Guayama, 00784, Puerto Rico

Location

University of Puerto Rico - Medical Sciences Campus

San Juan, 00935, Puerto Rico

Location

Synergy Biomed Research Institute

East London, Eastern Cape, 5201, South Africa

Location

Jaymed Research

Welkom, Free State, 9460, South Africa

Location

REIMED Reiger Park

Boksburg, Gauteng, 1459, South Africa

Location

Wits RHI

Johannesburg, Gauteng, 2001, South Africa

Location

University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)

Johannesburg, Gauteng, 2013, South Africa

Location

Wits VIDA Nkanyezi Research Unit

Johannesburg, Gauteng, 2093, South Africa

Location

Newtown Clinical Research

Johannesburg, Gauteng, 2113, South Africa

Location

Botho Ke Bontle Health Services

Pretoria, Gauteng, 0184, South Africa

Location

Sandton Medical Research Centre

Sandton, Gauteng, 2196, South Africa

Location

Gole Biomed Research Centre

Polokwane, Limpopo, 0699, South Africa

Location

Merclinco

Middelburg, Mpumalanga, 1055, South Africa

Location

Perinatal HIV Research Unit (PHRU)

Klerksdorp, North West, 2571, South Africa

Location

TREAD Research

Cape Town, Western Cape, 7530, South Africa

Location

Tsitsikamma Clinical Research Initiative (TCRI)

Plettenberg Bay, Western Cape, 6600, South Africa

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: September 23, 2022
• Primary Completion (Estimated): July 23, 2026
• Study Completion (Estimated): July 23, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (14); US (72); PR (2); BR (5); ME (3)